Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004604
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2000-05-02
Brief Title:
Biological Therapy in Treating Patients With Metastatic Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed Autologous Human Cultured Dendritic Cells in Patients With Metastatic Malignancies Expressing Carcinoembryonic Antigen
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the safety and dose limiting toxicity of an intravenous vaccine of autologous cultured dendritic cells pulsed with carcinoembryonic antigen CEA RNA in patients with metastatic adenocarcinoma expressing CEA II Assess the cellular immune response to the CEA protein III Assess the clinical and biochemical response to the treatment and the duration of such response
OUTLINE This a three tiered open label uncontrolled dose escalation study The first 3 patients receive a low dose of intravenous carcinoembryonic antigen CEA RNA-pulsed autologous dendritic cells DC at weeks 0 1 2 and 3 Patients are evaluated for dose limiting toxicity DLT immune response and the antitumor response for at least 1 week before dose escalation may proceed If there is no DLT in the first three the next 3 patients are treated at a medium dose of CEA RNA-pulsed autologous DC at 0 1 2 and 3 weeks Finally if DLT is not seen at the medium dose the final 6 patients receive intravenous infusions of a high dose of CEA RNA-pulsed autologous DC at weeks 0 1 2 and 3 If 1-2 patients experience DLT at the either the low or medium dose levels 3 more patients are entered at the same dose If no further DLT occurs then dose escalation continues As soon as 3 toxic events occur in 3-6 patients at one dose level accrual at that level ceases The MTD is defined as the dose level immediately below that at which more than 3 of 6 patients develop DLT
PROJECTED ACCRUAL A minimum of 3 and a maximum of 18 patients will be accrued for this study
OUTLINE This a three tiered open label uncontrolled dose escalation study The first 3 patients receive a low dose of intravenous carcinoembryonic antigen CEA RNA-pulsed autologous dendritic cells DC at weeks 0 1 2 and 3 Patients are evaluated for dose limiting toxicity DLT immune response and the antitumor response for at least 1 week before dose escalation may proceed If there is no DLT in the first three the next 3 patients are treated at a medium dose of CEA RNA-pulsed autologous DC at 0 1 2 and 3 weeks Finally if DLT is not seen at the medium dose the final 6 patients receive intravenous infusions of a high dose of CEA RNA-pulsed autologous DC at weeks 0 1 2 and 3 If 1-2 patients experience DLT at the either the low or medium dose levels 3 more patients are entered at the same dose If no further DLT occurs then dose escalation continues As soon as 3 toxic events occur in 3-6 patients at one dose level accrual at that level ceases The MTD is defined as the dose level immediately below that at which more than 3 of 6 patients develop DLT
PROJECTED ACCRUAL A minimum of 3 and a maximum of 18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1817 | OTHER | Duke IRB | None |